Combined Effect of Natural Killer Cell and Doublet Chemotherapy in Advanced NSCLC as the 1st Line Treatment
ANKL-2
Combined Effect of Autologous Ex-vivo Expanded Activated NK Cell-lymphocytes (ANKL) and Doublet Chemotherapy in Patients With Advanced NSCLC as the 1st Line Treatment; Phase II
1 other identifier
interventional
68
1 country
1
Brief Summary
The object of this study is to identify the combined effect of ANKL and doublet chemotherapy in advanced NSCLC. The investigators design the combination of ANKL and approved chemotherapy as the 3rd and 4th courses in the patients who get stable response after x2 induction as the first line chemotherapy. ANKL (2x10\*9) from peripheral blood 32ml is administered rapidly iv 12-36hr after each chemotherapeutic agents while peak effect of NK cell ligand modulation by chemotherapeutic agent is maintained. After 4th course, response evaluation is done by Response Evaluation Criteria in Solid Tumors (RECIST) and 40% or more partial response (PR, increased by 15% or more from historical control 25%) is the expected target and Simon's two stage design will be applied through the study (power 80%, a= 0.95, N1= 33, N= 68)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Feb 2015
Typical duration for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFebruary 3, 2017
February 1, 2017
3.5 years
February 1, 2015
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
confirmed response rate by CT scan
1 month later after 4th course
Secondary Outcomes (1)
progression free survival
6 months
Study Arms (1)
ANKL combined with chemotherapy
EXPERIMENTALcombination of ANKL and doublet chemotherapy as 3rd and 4th course in patients who get stable response after initial x2 courses
Interventions
add ANKL in 3rd and 4th course in case of stable response after two initial courses
Eligibility Criteria
You may qualify if:
- advanced NSCLC with measurable lesions,
- age of 20 - 75 years, Eastern Cooperative Oncology Group (ECOG)
- performance status (PS) of 0 to 2, and stable response after x2 induction chemotherapy as first line treatment.
- No major organ dysfunction.
You may not qualify if:
- pregnant or lactating woman,
- active hepatitis B or C,
- AIDS or positivity for HIV, autoimmune diseases or treatment with immunosuppressive drugs,
- prior radiotherapy to the target region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Daejeon St. Mary's Hospital
Jung-gu, Daejeon, 34943, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suk Young Park, MD, PhD
The Catholic University of Korea
- STUDY DIRECTOR
Hoon Kim, MD, PhD
The Catholic University of Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Medical Oncology, Dept of Internal Medicine
Study Record Dates
First Submitted
February 1, 2015
First Posted
February 24, 2015
Study Start
February 1, 2015
Primary Completion
August 1, 2018
Study Completion
February 1, 2020
Last Updated
February 3, 2017
Record last verified: 2017-02